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Stop that Monster Who Controls Your Supplements

 
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July 2014, in Rochelle, Georgia, the owner of a Dietary Supplement company was forced to stop selling and manufacturing its dietary supplements. Why? Its products were magically transformed into drugs, not because of the ingredients—those were all on the dietary supplement list—but rather because of words the formulator used to describe how the nutrients worked inside the human body.  Sadly, its customers from all over the world have been prevented from ordering products they had come to rely upon.

This is not the only story of its kind. Nearly every month a dietary supplement company is sent a warning letter or forced to shut down. Lately, the manufacturers are forced to destroy their products right along with American jobs, American freedom, and the American dream.

The FDA claims that they have no control over the dietary supplement industry. Yet, the fact is they control everything from manufacturing procedures to what a company can or cannot say about their product. A lot of this power is taken from a law passed in 1994 called the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Most consumers have not ever heard of DSHEA. This despite the fact that an amazing 78% of the US population over age 55 takes dietary supplements,  69 % of middle-agers (35-54 years) use supplements, and 60% of 18-34 year-olds increase their nutrient intake with dietary supplements. That equals an average of 69% of Americans that consume dietary supplements-- which is up 29% from the average in the years 1988-1994.

“Congress finds that improving the health status of United States citizens ranks at the top of the national priorities of the Federal Government; the importance of nutrition and the benefits of dietary supplements to health promotion and disease prevention have been documented increasingly in scientific studies;” (DSHEA, pg. 2, lines 2-9)

BioAnue Laboratories sold supplement formulas which were formulated carefully to insure they would really work to benefit the human body. Customers were finding real health benefits in using these supplements… all made in the USA. The company’s return policy gave the consumer 45 days to try the product or they could get their money back.

“[P]reventive health measures, including education, good nutrition, and appropriate use of safe nutritional supplements will limit the incidence of chronic diseases, and reduce long-term health care expenditures;” (DSHEA, pg. 2, lines 22-26)

In February 2012, the FDA sent Gloria Raber a warning letter. This agency did not approve of some websites not owned by BioAnue where BioAnue products were mentioned by name. The FDA wrote in the warning letter that BioAnue’s, "Bovine Cartilage," "TumorX BioEnerGenics Co-Enzyme -Q1O," "TumorX Cardio Clean," "Diabetic Mender," "TumorX Formula CX," and "Stroke Mender" products are promoted for conditions that cause these products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)].”  

The websites targeted by the FDA, www.tumorx.com and www.cancerx.org  was where Kelly Raber’s articles about health and science were posted. He is a researcher, writer, and was the formulator of the BioAnue, TumorX, and Med-Anue dietary supplement brands. He is also Gloria Raber’s husband.

Dr. Raber, as he is fondly called due to his degree in biochemistry, is a genius in his field. He has the ability to take seemingly unrelated concepts and merge them together into coherent lectures and articles that go far beyond education. His writings about how nutrients work inside the human body were not matched anywhere on the World Wide Web. He is an international lecturer on topics like cancer, heart disease, and adrenal fatigue. And his formulas have literally saved people’s lives.

“[C]onsumers should be empowered to make choices about preventive health care programs based on data from scientific studies of health benefits related to particular dietary supplements;” (DSHEA, pg. 2, lines 22-26). And, “[T]here is a definitive link between the ingestion of certain nutrients or dietary supplements and the prevention of chronic diseases such as cancer, heart disease, and osteoporosis;” (DSHEA, pg. 1, lines10-13)

Six months after the warning letter, FDA Agents from as far away as North Carolina showed up unnounced at BioAnue Laboratories Inc. At first they did not want to inspect the manufacturing facilities; they only wanted to speak with Mrs. Raber about the February Warning letter. But when Mrs. Raber would not readily speak to them without her attorney present, the agents turned their attention to something they had the power to do: perform a facility inspection.

“I was given the distinct impression that should I consent to speak with them about the warning letter, they would waive the facility inspection,” recalls Mrs. Raber. “Strange, because they are required to inspect facilities every 2 years according to their own regulations.”

“[A]lthough the Federal Government should take swift action against products that are unsafe or adulterated, the Federal Government should not take any actions to impose regulatory barriers limiting or slowing the flow of safe products and needed information to consumers; dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare;” (DSHEA, pg. 4, lines 17-25)

With new regulations added each year, there was no surprise that the FDA’s inspection led to citations for BioAnue. But after BioAnue made the necessary changes things turned even worse: the Department of Justice sent a letter giving Mrs. Raber the option to willingly close her company down permanently, or face a lawsuit from the United States of America. The fighter in Mrs. Raber won.

Both Mrs. and Mr. Raber were named in the lawsuit. And it was Mr. Raber’s writings and video lectures which ultimately caused the Federal Judge to issue the Permanent Injunction against BioAnue Laboratories Inc.

“We had planned to cite from DSHEA when our day for court came, but things didn’t turn out at all like we had envisioned,” said Gloria Raber. “My husband and I weren’t even allowed to speak!”

Obama-appointed, Federal Judge Marc T. Treadwell was an obvious proponent of the FDA. After viewing Mr. Raber’s video lecture on cardiovascular disease in the courtroom, Treadwell decided that Kelly Raber’s articles and video lectures did indeed make Gloria Raber’s dietary supplements unapproved drugs.

Never was there an accusation that BioAnue’s products were adulterated with unapproved ingredients or unsanitary and unsafe. No consumer had filed a complaint against the company. There was not anyone who had even alleged to being harmed. This was all about speech: Stealing Kelly Raber’s freedom of speech; stealing the citizens’ freedom to read the speech. And Gloria Raber was the conduit between the FDA, her husband, and the consumer.

Congress had specified in DSHEA that, “[T]he burden of proof is on the Food and Drug Administration to prove that a product is unsafe before it can be removed from the marketplace;” (DSHEA, pg. 5, lines 24-25 & pg. 6, lines 1-2)

Emails, voicemails, and letters poured in from customers all over the world. The customers claimed that their health was suffering without BioAnue products. Cancer gone in remission while using Dr. Raber’s formulas had now returned. Diabetics relieved of their diabetes were forced to return to prescriptions that they claimed did not work. Adrenal fatigue, stroke, Alzheimer’s, and high blood pressure—these and more were reasons that customers had been using Dr. Raber’s formulas. The general well-being of the customers was in decline.

The injunction included a list of things to be done so that the Raber’s could gain the FDA’s favor and receive permission to sell dietary supplements again. They would be subject to frequent inspections should they ever reach the graces of the agency, but at least there was a way out. In fact, it seemed pretty straight forward: follow the list and get re-opened.

Stacks of supporting documents were rushed off the DOJ which showed the Raber’s compliance with the injunction. A third-party inspection was completed and reports were drafted and sent off to the DOJ. Months passed with no reply from the DOJ or the FDA.

The Rabers contacted their congressman and senators and urged the customers to do the same. Congressman Scott commented to the Rabers about how the non-elected government agencies really did not take him and his colleagues seriously. So while he promised to send in an inquiry to the FDA and DOJ, he did not seem surprised by the regulatory problems.

Later a statement was issued by Congressman Scott’s office saying that they had received a reply from the FDA (which was nothing more than the FDA’s own press release about BioAnue). The Congressman could do no more. How frustrating to have ones congressman believe every word a non-elected agency had to say regarding a case! What had happened to representation and oversight?

Gloria Raber has an answer. “When Americans shrank away from personal responsibility, the government came to the rescue,” she said. “Our government has created numerous agencies to control different aspects of its citizens. Now these agencies are our nightmares--monsters that have driven businesses off our shores and left our citizens without jobs, products, and freedom. And,” she added emphatically, “This monster is taking our health.”

In the world of medicine and food someone ultimately gets sick, someone dies. Often it is an outbreak of sickness and often even death. This is sad, but true. Accidents happen. Nothing can ever be 100% safe. But the public has always wanted someone to blame in these unfortunate situations. Always there is a leader who promises to “fix the problem.” A new law will prevent this calamity from ever happening again. Thus a new agency is formed, new laws are passed.  All is well again.

That is how the FDA was conceived. The late 1800’s brought zeal to regulate “misbranded” products, “unethical claims” on drug labeling, and “adulterated” products which contained fillers and harmful coloring agents (which, by the way, the FDA now deems safe to use in our food). All this seemed good.

By 1938, the FDA had been given its official name and its power was expanded to include pre-market review of new drugs, banning false therapeutic claims of drugs, the power to set regulatory standards for drugs, food, and therapeutic devices, and the authority to inspect the drug and food factories.

The FDA is even bigger today. Their own website states, “The scope of FDA’s regulatory authority is very broad. FDA's responsibilities are closely related to those of several other government agencies. Often frustrating and confusing for consumers is determining the appropriate regulatory agency to contact.”

So what can the average citizen do to fight back against this monster? It was the people who created this monster; it’s the people’s responsibility to put it a cage.

“We urge everyone who takes supplements to write their senators and congressman and tell them to uphold the law, DSHEA,” says Mr. and Mrs. Raber. “The supplement company you rely upon for your health could be next on the shutdown list. If enough of us speak out, we can make something happen.”

# # #

Write your Represenatives and the Government Oversight Committee. Click here to get a sample letter.

Read the Permanent Injunction

 

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